Assessment of Safety and Accuracy of the Microtech System in Patients Undergoing Left Ventricular Assist Device Implantation

Part of paid clinical trials in New York, New York.

Sponsor
Microtech Medical Technologies, Ltd
Study ID
NCT06682910
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Microtech sensor pressure — DEVICE
    Microtech sensor implantation

Study Details

The Microtech-LVAD study is designed as a prospective, single arm, multi-center early feasibility study. Approximately 15 patients will be enrolled in the study. The study will be limited to patients in whom it is decided, based on routine clinical practice, that the LVAD will be implanted via a midline sternotomy. In the first 5 study patients, the device will be implanted in the RA; subsequently, the device will be implanted in the LA unless the patient is deemed at high risk of post-LVAD right heart failure, in which case the device will be placed in the RA

Key Dates

Start date
Dec 15, 2024
Status verified
Mar 2025
Primary completion
May 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Microtech System
    Microtech System

Primary Outcome Measure

Co-Primary Efficacy Endpoint [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Medical Center/ NewYork Presbyterian Hospital or CUMC/NYPHNew YorkNew York10032
Kate Dalton
[email protected]
347 514-3366

Find similar trials in New York, NY

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Columbia University Medical Center/ NewYork Presbyterian Hospital or CUMC/NYPH· New York, NY

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